Norepinephrine Injectable Solution

Brand(s)
Levophed
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Parenteral Medicines, Inc (2015-10-29)
Oldest Current Product
1950-07-13
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\NOREPINEPHRINE
FDAOB
INJECTION\INJECTION\NOREPINEPHRINE BITARTRATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\NOREPINEPHRINE BITARTRATE
INTRAVENOUS\INJECTION, SOLUTION\NOREPINEPHRINE BITARTRATE
INTRAVENOUS\INJECTION\NOREPINEPHRINE BITARTRATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\NOREPINEPHRINE
INTRAVENOUS\INJECTION, SOLUTION\NOREPINEPHRINE
INTRAVENOUS\INJECTION\NOREPINEPHRINE

product(s) by strength(s)

norepinephrine 0.016 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330134UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2015-02-20NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION, SOLUTION40fd45b4-d955-4fea-b891-32eae19ab25e
2525330165UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2015-03-06NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION, SOLUTION71f901b5-022b-43ea-b1a0-29adc9a1f718

norepinephrine 0.032 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330166UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2015-03-06NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION, SOLUTION997f00c2-affb-4af1-bdff-7ceb418df696
2525330217UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2015-02-18NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION, SOLUTION1093e746-cb28-4537-becb-b84670b88309

norepinephrine 0.064 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330164UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2015-03-12NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION, SOLUTION2ba1f768-ccc7-41d0-8039-ccb81931fedd

norepinephrine 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093375LevophedNDAHospira, Inc.1950-07-13NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA007513c4de72a8-2a75-4984-ce90-e4870226dc12, d2b5320e-e6a6-4a43-8f3c-9c21195ceb4a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007031153ANDATeva Parenteral Medicines, Inc2003-04-01NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA040455521b3175-d997-494f-9722-74246fe4f55d
2360000162ANDAClaris Lifesciences Inc.2012-04-01NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTIONANDA040859a27fb6e0-8f7a-11db-9739-0050c2490048

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840443LevophedNDAGeneral Injecatables & Vaccines, Inc2010-03-01NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE004091443NDA0075134d3531fb-82a4-41ab-8c36-eb0aace61f5c
2551540454ANDACardinal Health2003-03-03NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION007031153ANDA0404553352c7d0-e621-46ed-9a54-e4a9583cde10
3551543185LevophedNDACardinal Health1982-01-01NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE004093375NDA0075138c9dc6eb-e53a-4cc0-92c3-7a53d268cf93
4551544450ANDACardinal Health2012-04-01NOREPINEPHRINE BITARTRATEINTRAVENOUSINJECTION360000162ANDA0408590b8896b6-b8ac-4d04-9d5f-60c21404e159

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040455NOREPINEPHRINE BITARTRATETEVA PHARMACEUTICALS USA2003-03-03ANDA040455_001
2ANDA040462NOREPINEPHRINE BITARTRATEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2003-10-31ANDA040462_001
3ANDA040522NOREPINEPHRINE BITARTRATETrueMETRICS PHARMACEUTICAL VENTURES LLC2004-09-30ANDA040522_001
4ANDA040859NOREPINEPHRINE BITARTRATECLARIS LIFESCIENCES LTD2012-03-27ANDA040859_001
5NDA007513LEVOPHEDHOSPIRA INCNDA007513_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040455_001RXNOREPINEPHRINE BITARTRATE (EQ 1MG BASE/ML)INJECTIONFalseAP2003-03-03NOREPINEPHRINE BITARTRATE
2ANDA040462_001RXNOREPINEPHRINE BITARTRATE (EQ 1MG BASE/ML)INJECTIONFalseAP2003-10-31NOREPINEPHRINE BITARTRATE
3ANDA040522_001discontinuedNOREPINEPHRINE BITARTRATE (EQ 1MG BASE/ML)INJECTIONFalse2004-09-30NOREPINEPHRINE BITARTRATE
4ANDA040859_001RXNOREPINEPHRINE BITARTRATE (EQ 1MG BASE/ML)INJECTIONFalseAP2012-03-27NOREPINEPHRINE BITARTRATE
5NDA007513_001RXNOREPINEPHRINE BITARTRATE (EQ 1MG BASE/ML)INJECTIONTrueAPLEVOPHED

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b8896b6-b8ac-4d04-9d5f-60c21404e159 (view SPL)Norepinephrine Bitartrate Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-02-262551544450
21093e746-cb28-4537-becb-b84670b88309 (view SPL)Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-02-181525330217
32ba1f768-ccc7-41d0-8039-ccb81931fedd (view SPL)Norepinephrine Bitartrate 16 mg Added to 5% Dextrose 250 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-03-121525330164
42e0570e7-d28f-4936-cba8-81ee0c4c3547 (view SPL)LevophedTMprescriptionHuman PrescriptionHospira, Inc.2012-07-0310004091443
53352c7d0-e621-46ed-9a54-e4a9583cde10 (view SPL)Norepinephrine Bitartrate Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2011-05-251551540454
640fd45b4-d955-4fea-b891-32eae19ab25e (view SPL)Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-02-231525330134
74d3531fb-82a4-41ab-8c36-eb0aace61f5c (view SPL)Levophed (Norepinephrine Bitartrate) 4 mg Injection, USP 4 mL AmpuleprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-04-023525840443
8521b3175-d997-494f-9722-74246fe4f55d (view SPL)Norepinephrine Bitartrate Injection USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-10-294007031153
971f901b5-022b-43ea-b1a0-29adc9a1f718 (view SPL)Norepinephrine Bitartrate 4 mg Added to 5% Dextrose 250 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-03-061525330165
108c9dc6eb-e53a-4cc0-92c3-7a53d268cf93 (view SPL)LEVOPHED Norepinephrine Bitartrate Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-222551543185
11997f00c2-affb-4af1-bdff-7ceb418df696 (view SPL)Norepinephrine Bitartrate 8 mg Added to 5% Dextrose 250 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-03-061525330166
12a27fb6e0-8f7a-11db-9739-0050c2490048 (view SPL)Norepinephrine Bitartrate Injection, USPprescriptionHuman PrescriptionClaris Lifesciences Inc.MANUFACTURE2015-06-297360000162
13bb5e8d16-303f-49fc-8424-d57ce41b588d (view SPL)Levophed Norepinephrine Bitartrate Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-04-281004091443
14c4de72a8-2a75-4984-ce90-e4870226dc12 (view SPL)LEVOPHEDprescriptionHuman PrescriptionHospira, Inc.2012-06-2110004093375
15d2b5320e-e6a6-4a43-8f3c-9c21195ceb4a (view SPL)Levophed Norepinephrine Bitartrate Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-04-281004093375

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII